Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05048966 | RECRUITING | Traumatic Brain Injury

Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons
Sponsor:

Kessler Foundation

Information provided by (Responsible Party):

Denise Krch

Brief Summary:

Approximately 5.3 million people live with a long-term disability resulting from a traumatic brain injury (TBI) and between 5-8% of those older than 60 suffer from Alzheimer's disease or other forms of dementia (ADRD). Consequences of these conditions can result in dramatic and persistent changes in functioning, impacting not only the patients, but also loved ones who become informal support persons. Many existing services help the family in the moment, but do not address long-term wellness. Thus, the purpose of this research study is to compare the effect of two different types of group wellness treatments for individuals with chronic mild TBI, moderate to severe TBI, and ADRD and their support persons.

Condition or disease

Traumatic Brain Injury

Mild Traumatic Brain Injury

Alzheimer's Disease

Brain Injury Traumatic Moderate

Brain Injury Traumatic Severe

Dementia

Intervention/treatment

Group Wellness Class 1

Group Wellness Class 2

Phase

NA

Detailed Description:

The study will involve three sites, with a different clinical population targeted at each site. Kessler Foundation will serve as the Coordinating Center and will enroll individuals with moderate/severe TBI. Franciscan Health in Indiana and University of Michigan will serve as partnering sites and will enroll individuals with chronic mild TBI and ADRD respectively. The research protocols at each site will be unique to the patient population, but harmonized through unified project goals: 1) to evaluate the efficacy of two different online group wellness treatments designed to improve self-efficacy and quality of life, and 2) to determine whether patient neurobehavioral functioning moderates the relationship between treatment outcomes and burden in caregivers, and 3) to determine the neural, behavioral, and blood biomarkers that best predict treatment efficacy. It is expected that findings generated from this study will lead to improved holistic approaches for brain injury and dementia systems of care.

Study Type : INTERVENTIONAL
Estimated Enrollment : 360 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons: A Randomized Clinical Trial
Actual Study Start Date : 2022-12-08
Estimated Primary Completion Date : 2025-09
Estimated Study Completion Date : 2025-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
For individuals with moderate/severe TBI
  • Inclusion Criteria
    • * age 18-64
    • * at least one year post injury
    • * can read and speak English fluently
    • * has a support person who is willing to participate in the study
    Exclusion Criteria
    • * has had a prior stroke or neurological disease other than TBI
    • * has unstable or uncontrolled seizures
    • * has been hospitalized due to a significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) in the past three months
    • * current alcohol and/or drug use that interferes with ability to carry out common everyday functions
    • For individuals with chronic mild TBI
      • Inclusion Criteria
        • * age 18-64
        • * at least 3 months post-injury
        • * can read and speak English fluently
        • * has a support person who is willing to participate in the study
        Exclusion Criteria
        • * has had a prior stroke or neurological disease other than mild TBI
        • * has unstable or uncontrolled seizures
        • * has been hospitalized due to a significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) in the past three months
        • * current alcohol and/or drug use that interferes with ability to carry out common everyday functions
        • For Individuals with Alzheimer's Disease Related Dementias (ADRD)
        • Inclusion Criteria
          • * age 65 and older
          • * at least one-year post-diagnosis
          • * can read and speak English fluently
          • * has a support person who is willing to participate in this study
          Exclusion Criteria
          • * has had a prior stroke or neurological disease other than ADRD
          • * has unstable or uncontrolled seizures
          • * has been hospitalized due to a significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) in the past three months
          • * current alcohol and/or drug use that interferes with ability to carry out common everyday functions
          • For Support Persons
            • Inclusion Criteria
              • * is the support person of an individual with moderate/severe TBI, chronic mild TBI or ADRD who is willing to participate in the study
              • * can read and speak English fluently
              Exclusion Criteria
              • * has a significant neurological history (e.g. stroke or multiple sclerosis)
              • * has unstable or uncontrolled seizures
              • * has been hospitalized due to a significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) in the past three months
              • * current alcohol and/or drug use that interferes with ability to carry out common everyday functions
Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons

Location Details

NCT05048966

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New Jersey

Kessler Foundation

East Hanover, New Jersey, United States, 07936